Device product
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Z-2531-2025
Product summary
- Event
- Event 97452
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 228 units
- Official record key
device-enforcement:Z-2531-2025
Official wording
Reason: Potential for open header bag seals, compromising sterility.
Code information: Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.
Distribution pattern: US Nationwide distribution in the state of Florida.
Derived failure modes
-
Unknown
Potential for open header bag seals, compromising sterility.